MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number	512100350060
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 3.5mm coupler had a curved needle on one side and three curved needles on one side.This issue was identified during setup and preparation prior to patient use.A new product of the same model was used with no issues.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Upon visual inspection of the 3.5mm coupler jaw assembly, no signs of use were visible on the coupler rings which was consistent with the complainant¿s statement that the bent pin on the coupler assembly was found prior to use.While viewing the returned 3.5mm jaw assembly, bent pins were visible on the right ring of the jaw assembly.When viewing the left ring, a bent pin was visible.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER
• Common Device Name: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10438004
• Report Number: 1416980-2020-05135
• Device Sequence Number: 16864098
• Product Code: MVR
• UDI-Device Identifier: 10844735002703
• UDI-Public: 10844735002703
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 512100350060
• Device Lot Number: SP19G09-1383722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1